Multiomic Analysis of Serum in Acute Period of Traumatic Brain Injury (MASTER-TBI)

September 1, 2024 updated by: Junfeng Feng, RenJi Hospital

Proteomic and Metabolomic Detection and Analysis of Serum from Patients with Acute Severe Traumatic Brain Injury: a Prospective, Multicentered Study

The goal of this experimental observation study is to figure out differently expressed biomarkers in serum in traumatic brain injury patients, compared with bone fracture patients. The main questions it aims to answer are:

  1. Which proteins and metabolites are differently expressed in TBI patients' serum?
  2. Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? Participants will be treated by routine treatments, and their serum samples will be collected in the emergency room.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This experimental observation study is designed to find out some new characteristics in acute severe traumatic brain injury. To filter the stress response in blood, patients with traumatic fracture are chosen as the control group.

Blood samples of patients who pass the eligibility criteria will be collected immediately in the emergency room. Then the samples will be preprocessed in the laboratory to get serums. These collected serums will be preserved in -80℃ until completing all sample collection. After completing collection, all samples will be sent to proteomic and metabolomic detection. The bioinformatic data will be analyzed to answer these main questions:

  1. Which proteins and metabolites are differently expressed in TBI patients' serum? (As a whole characteristic of acute severe TBI)
  2. Which proteins or metabolites can serve as the new serum biomarkers for diagnosing TBI? (Deeply digging the value of characteristic of acute severe TBI)

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201114
        • Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:
        • Principal Investigator:
          • Junfeng Feng, Ph.D.
        • Sub-Investigator:
          • Jiyuan Hui, Ph.D.
        • Sub-Investigator:
          • Ru Gong, Ph.D.
        • Sub-Investigator:
          • Weiji Weng, Ph.D.
        • Sub-Investigator:
          • Weiyuan Xiao, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients in the case group are these with brain injury, caused by trauma and are severe (GCS 3-8) and in acute period (within 12 hours). Meanwhile, these patients should not have acute bone fracture or other orthopaedic diseases, to avoid any biological detecting bias to control group.

Patients in the control group are these with bone fracture, caused by trauma and in acute period (within 12 hours). Also, these patients should not have acute brain injury or other neurological diseases to avoid the same bias in biological detection.

Description

Inclusion Criteria:

  • With cerebral contusion in 24Hrs for case group, or with traumatic bone fracture in 24Hrs for control group.
  • The Glasglow Coma Scale ranges in 3-8 for case group.
  • Need to have routine laboratory examination of blood sample.
  • Patients or agents sign the informed consent.

Exclusion Criteria:

  • With bone fracture for case group, or with brain injury for control group.
  • Have Orthopaedic history for case group, or have Neurological history for control group.
  • Death in 24 hours.
  • Immunosuppressed state.
  • Severe multiple organ dysfunction.
  • With infection.
  • Pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case group
This group enrolls patients with acute severe traumatic brain injury.
Other: Type of trauma
Patients in case group have the severe traumatic brain injury, while patients in control group have the traumatic bone fracture without brain injury.
Control group
This group enrolls patients with acute traumatic bone fracture but without traumatic brain injury.
Other: Type of trauma
Patients in case group have the severe traumatic brain injury, while patients in control group have the traumatic bone fracture without brain injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of differently expressed proteins in patients' serum detected by proteomic
Time Frame: First 12 hours in the emergency room
Patients' serum will be collected in the emergency room. After collecting all samples, these samples will be detected through proteomic mass spectrometry. The results of proteomic will be further analyzed and compared with control group to filter potential protein biomarkers in serum of severe TBI patients in acute phase.
First 12 hours in the emergency room
Number of differently expressed metabolites in patients' serum detected by metabolomic
Time Frame: First 12 hours in the emergency room
Patients' serum will be collected in the emergency room. After collecting all samples, these samples will be detected through metabolomic mass spectrometry. The results of metabolomic will be further analyzed and compared with control group to filter potential metabolite biomarkers in serum of severe TBI patients in acute phase.
First 12 hours in the emergency room

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Junfeng Feng, Ph.D., Renji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Estimated)

September 5, 2024

Last Update Submitted That Met QC Criteria

September 1, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2024-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Traumatic Brain Injury

Clinical Trials on Type of trauma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe